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Study guide for exam 1,2,3

by: Kathleen Quijada

Study guide for exam 1,2,3 BME 4100

Kathleen Quijada
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Hey guys! This is Biomaterials with Dr. Christie, this is my notebook for that class, you may need it for to study for his test! Please download & Enjoy!
Dr. Michael Christie
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This 378 page Bundle was uploaded by Kathleen Quijada on Tuesday December 22, 2015. The Bundle belongs to BME 4100 at Florida International University taught by Dr. Michael Christie in Fall 2015. Since its upload, it has received 75 views. For similar materials see Biomaterials in Biomedical Sciences at Florida International University.

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Date Created: 12/22/15
materials RNOTEIOO : BME 4100 BIOMATERIALS Summer 2015 __________________________________________________________________ INSTRUCTOR: M. Christie Classroom: EC 1105 TIME: MWF 9:30 AM – 11:45 PM OFFICE: EC 2763 PHONE: 305-348-7392 EMAIL: Office Hours: W 3:00 PM-4:00 PM or by appointment TEACHING ASSISTANT: TBA OFFICE: TBA TA OFFICE HOURS: TBD EMAIL: TEXT: Biomaterials :An Introduction, 3 Ed. Joon Parks & R. S. Lakes. Springer, NY, 2007 COURSE OBJECTIVES: This purpose of this course is to provide the scientific foundation for the use of engineered materials in the human body for the purposes of aiding healing, correcting deformities, and restoring lost function. The major goal of the course is to develop in the student a familiarity with the uses of materials in medicine and a rational basis for these applications. At the conclusion of this course, the student should be able to: 1. Apply basic engineering techniques and principles to predict and interpret the structure of solids, gels, etc`. 2. Demonstrate clear understanding of process-property relationships in engineered materials 3. Demonstrate proficiency in the basic principles of some selected materials evaluation and analytical techniques. 4. Demonstrate proficiency in the understanding of characterization and modeling of the structure-property relationships of biological materials and the principles of biocompatibility. 5. Determine materials choices taking into account the structure-property relationships of the material (metal, ceramic, polymer, composite), as well as the medical application (soft or hard tissue replacement/augmentation). 6. Prepare and present a conceptual design which demonstrates all of the course objectives through a group project which will be approved by the instructor. COURSE DESCRIPTION: Thecontentsofthecourseincludebiocompatibility,techniquestominimizecorrosionorother degradation of implant materials, principles of materials science as it relates to the use of materials in the body, and specific uses of materials in various tissues and organs. Topics covered include properties of metals, polymers, ceramics, composites, biomaterials processing, evaluation, and biocompatibility. Topics to be introduced include strengthening techniques and specials effects in selected materials, including, superplasticity, superelasticity, piezoelectricity, pyroelectricity, nanoscale materials and processing and bioengineered materials. POINTS DISTRIBUTION: Exam I Exam II Exam III Group Project 30% 30% 30% 10% Policy regarding student misconduct: Students at Florida International University are expected to adhere to the highest standards of integrity in every aspect of their lives . Honesty in academic matters is part of this obligation. Academic integrity is the adherence to those special values regardinglifeand workin an academiccommunity.Anyactoromission by astudentwhich violatesthisconceptofacademicintegrityshall bedefined as academic misconduct and shall be subject to the procedures and penalties established by the university . Students violating academic integrity will receive a failing grade for the course and the incident will be forwarded to Student Academic Affairs. Academ ic misconduct includes, but is not limited to, copying homework, copying work on exams either in -class or take -home,copyingofprojects,orplagiarism. Plagiarism is using others' ideas and words without clearly acknowledging the source of that information. This includes, but is not limited to, the internet, textbooks, journals, or any other material that is not your own work. It is the responsibilityofstudentstoreportmisconduct,which mayincludeanother student copying from your,or a notherstudent’sexam,homework,projects or any other assignment.Therefore,ifa student copiesfrom you,it isyour responsibility to report it, otherwise you are also responsible. Under no circumstances will any student be permitted to leave and return to the classroom during an exam . Any student who must miss the exam needs to notify the instructor or departmentalsecretary prior toexam timeand havedocumentation for the reason. Turn off cell phones before entering class. BME 4100 BIOMATERIALS SCIENCE Fall 2015 __________________________________________________________________ COURSE OUTLINE ______________________________________________________________________________ Week # CHAPTER TOPIC 1 Introduction and Overview of Biomaterials 1 Bonding and Microstructure of the Solid State 1 Structure and Properties of Metals 2 “ “ “ Polymers 2 “ “ “ Ceramics 2 Composites and Special effects in solids EXAM I ~5/25/15 3 Characterization of Materials 3 Biomaterials Testing & Standards: ISO, USP, ASTM, NIST 3 Degradation 4 Structure-Property Relationships of Biological Materials 4 Biocompatibility 4 Metallic Implant Material: EXAM II ~6/8/15 5.5 5 Ceramic Implant Materials 5 Polymeric and Composite Implant Materials 5 Gels and smart material implants 6 Soft Tissue Replacement 6 Hard Tissue Replacement 6 Sterilization/ Intro to Tissue Eng’g FINAL (EXAM III) ~6/19/15 Group project = after first test 1 INTRODUCTION Illustrations of various implants and devices used to replace or enhance the function of diseased Wiley.sing tissues and organs. Adapted with permission from Hill (1998). Copyright © 1998, 1 ~ Introduction test 1 㱺 Chapters 1-4 what is a material : It basically matter Materials can be use to dose wounds back . the day materials that are Used for Arms race ... Biomometicmatrials = / war armor , suits - what is Biomaterials ? Can be defined as any material Used to make devices to replace a part of Or a Function of the body ina safe , reliable , economic 4 physiologically acceptable manner : - Sutures , needles , catheters bone plates EX , - used to treat disease 4 injury Some other like tools for a metal opener for surgery , it has to be bio things surgery pharmacologically inert not Biological materials - a material such as contact W skin such aids wearable artificial limbs /the , as hearing , 0 acceptance pharmacological !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ2  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ   !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ3  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ inert / stable chemically Adequate  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ4  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ  life !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ5  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ fulzive afortabk !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ6  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~€‚ƒ„…†‡ˆ‰Š‹ŒŽ‘’“”•–—˜™š›œžŸ ¡¢£¤¥¦§¨©ª«¬­®¯°±²³´µ¶·¸¹º»¼½¾¿ÀÁÂÃÄÅÆÇÈÉÊËÌÍÎÏÐÑÒÓÔÕÖ×ØÙÚÛÜÝÞßàáâãäåæçèéêëìíîïðñòóôõö÷øùúûüýþÿ to be approved by the FDA 2 * needy things efficacy - safety It needs to do its function - PH has to tow I everything with corresionn Biocompatibility Qacuk Systemic toxicity , cytotoxicity , Haemolysis . . . States for United Farmocopia 㱺 tests that are used 4 they deal with protocols products to exam biomaterials For efficacy - ISO 㱺 International stand erization it has similar tests like VSF it looks for color changes organization ; , exams for rungancy - British 4 ease ( farm Japan company ocopia ) after developing a devices we would have to Sterilize it , . * Dental / cosmetics ¥ need to have biomaterials things like an artificial kidney , sometimes it is not compatible , so it can de a disadvantage , more $$ denswes , not biomaterial always 4 Major factors that contribute to implants - infection - wear - loosening - fracture Bionic is not the same as a pnstetic leg leg 2 CH .1:INTRODUCTION 1.1. DEFINITION OF BIOMATERIALS A biomaterial can be defined as any material used to make devices to replace a part or a func- tion of the body in a safe, reliable, economic, and physiologically acceptable manner. Some people refer to materials of biological origin such as wood and bone as biomaterials, but in this book we refer to such materials as “biological materials.” A variety of devices and materials is used in the treatment of disease or injury. Commonplace examples include sutures, tooth fill- is ings, needles, catheters, bone plates, etc. A biomaterial is a synthetic material used to replace part of a living system or to function in intimate contact with living tissue. The Clemson Uni- versity Advisory Board for Biomaterials has formally defined a biomaterial to be “a systemi- -Function cally and pharmacologically inert substance designed for implantation within or incorporation -Bio with living systems.” These descriptions add to the many ways of looking at the same concept compatible but expressing it in different ways. By contrast, a biological material is a material such as bone, skin, or artery produced by a biological system. Artificial materials that simply are in - intimate contact } contact with the skin, such as hearing aids and wearable artificial limbs, are not included in our definition of biomaterials since the skin acts as a barrier with the external world. interacting Because the ultimate goal of using biomaterials is to improve human health by restoring the function of natural living tissues and organs in the body, it is essential to understand rela- tionships among the properties, functions, and structures of biological materials. Thus, three aspects of study on the subject of biomaterials can be envisioned: biological materials, implant materials, and interaction between the two in the body. FDA 2 * to be approved by the things - artifical bones needy efficacy - - safety biodegradable Figure 1-1. Schematic illustration of biocompatibility. Modified with permission from Hill (1998). Copyright © 1998, Wiley. B IOMATERIALS :A N INTRODUCTION 3 The success of a biomaterial or an implant is highly dependent on three major factors: the properties and biocompatibility of the implant (Figure 1-1), the health condition of the recipi- ent, and the competency of the surgeon who implants and monitors its progress. It is easy to understand the requirements for an implant by examining the characteristics that a bone plate must satisfy for stabilizing a fractured femur after an accident. These are: 1. Acceptance of the plate to the tissue surface, i.e., biocompatibility (this is a broad term and includes points 2 and 3) 2. Pharmacological acceptability (nontoxic, nonallergenic, nonimmunogenic, noncarcinogenic, etc.) 3. Chemically inert and stable (no time-dependent degradation) 4. Adequate mechanical strength 5. Adequate fatigue life how before it breaks ( long ) 6. Sound engineering design 7. Proper weight and density 8. Relatively inexpensive, reproducible, andeasytofabricateandprocessfor large-scale production Development of an understanding of the properties of materials that can meet these re- quirements is one of the goals of this book. The list in Table 1-1 illustrates some of the advan- tages, disadvantages, and applications of four groups of synthetic (manmade) materials used for implantation. Reconstituted (natural) materials such as collagen have been used for re- placements (e.g., arterial wall, heart valve, and skin). are more Cosmetics : Breast pinnts , teeth Polymers whitening Complex Table 1-1. Class of Materials Used in the Body Materials Advantages Disadvantages Examples Polymers (nylon, silicone Resilient Not strong Sutures, blood vessels rubber, polyester, Easy to fabricate Deforms with time other soft tissues, sutures, polytetrafuoroethylene, etc) May degrade hip socket, ear, nose Metals (Ti and its alloys, Co–Cr Strong, tough May corrode Joint replacements, dental alloys, Au, Ag stainless steels, etcductile Dense root implants, pacer and Difficult to make suture wires, bone plates and screws Ceramics (alumina zirconia, Very bio- Brittle Dental and orthopedic calcium phosphates including compatible Not resilient implants hydroxyapatite, carbon) Weak in tension Composites (carbon–carbon, Strong, tailor- Difficult to make Bone cement, wire- or fiber- reinforced made Dental resin bone cement) The materials to be used in vivo have to be approved by the FDA (United States Food and Drug Administration). If a proposed material is substantially equivalent to one used before the FDA legislation of 1976, then the FDA may approve its use on a Premarket Approval (PMA) basis. This process, justified by experience with a similar material, reduces the time and ex- pense for the use of the proposed material. Otherwise, the material has to go through a series of “biocompatibility” tests. In general biocompatibility requirements include: . s s e c o r p h c a e f o s t c e f f e e v i t a l umuC . s t c udo r p no i t a d a r g eD . y t i l i b a t i u s ) s ( l a i r e t am e h t e t a c i dn i d l uow h c i hw , e s u r o i r p f o f oo r p d e t n emu c oD e s r e vd a ( no i t c a e r l a i t n e t op gn i s s e s s a n i d i a d l uow t a h t s t s e t l a c i go l o i b nwonk f o . e s u dn a t c a t no c n i emi t s u l p ,mr o f , e z i s , e p a h s . t c udo r p e h t n i d e v l ovn i s l a i r e t am . s e u s s i t ydob e h t h t iw t c a t no c t c e r i d n i s l a i r e t am e s oh t no a t a d . s t c e f f e ] ) s e d i ug no i t a z i n a g rO d r a dn a t S l a no i t a n r e t n I ( . e c n a c i f i ng i s l a c i go l o c i xo t gn i du l c n i no i t amr o f n i B IOMATERIALS :A N NTRODUCTION Table 1-3. Criteria for Judgment and Registration of Bone Cements (McDermott, 1997) in the United States, as Specified by the Food and Drug Administration Parameter/test Property method Chemical composition Raw materials d e d d A components Purity Molecular weight (MW) Relative viscosity MW Physical properties Morphology Porosity Aging due to water uptake Handling properties Doughing time Setting time Intrusion/viscosity Polymerization Maximum temperature Shrinkage Degree of polymerization Content of residual monomer Release of residual monomer Stability Monomer stability (enforced) BPO content Doughing/setting time Modulus of elasticity Four-point bending Compression modulus Compression Tensile modulus Tensile strength Fatigue Tensile/compression fatigue; e u g i t a f e l i s n e t / e l i s n e t g n i d n e b t n i o p - r u o F Fracture toughness Compact tension/notched h t g n e r t s g n i d n e b Fatigue-crack propagation Compact tension Static strength ISO 5833 Flexural strength Four-point bending Compressive strength Uniaxial compression Tensile strength Uniaxial tension Shear strength Cement-cement shear; r a e h s t n a l p m i - t n e m e c Viscoelasticity DMA/compressive creep Shelf life See § of this text for many of the terms used in this table. Reprinted with permission from Kühn (2000). Copy- right © 2000, Springer. Another important area of study is that of the mechanics and dynamics of tissues and the resultant interactions between them. Generally, this study, known as biomechanics, is incorpo- rated into the design and insertion of implants, as shown in Figure 1-2. More sophisticated analysis can be made using computer methods, such as FEM and FEA (finite-element model- ing/analysis). These approaches help to design a better prosthesis or even custom make them for individual application. 6 CH .1:INTRODUCTION Table 1-4. Surgical Uses of Biomaterials Permanent implants Muscular skeletal system — joints in upper (shoulder, elbow, wrist, finger) and lower (hip, knee, ankle, toe) extremi- ties, permanently attached artificial limb Cardiovascular system — heart (valve, wall, pacemaker, entire heart), arteries, veins Respiratory system — larynx, trachea, and bronchus, chest wall, diaphragm, lungs, thoracic plombage Digestive system — tooth fillings, esophagus, bile ducts, liver Genitourinary system — kidney, ureter, urethra, bladder Nervous system — dura, hydrocephalus shunt Special senses — corneal and lens prosthesis, ear cochlear implant, carotid pacemaker Other soft tissues — hernia repair sutures and mesh, tendons, visceral adhesion Cosmetic implants — maxillofacial (nose, ear, maxilla, mandible, teeth), breast, eye, testes, penis, etc. Transient implants Extracorporeal assumption of organ function — heart, lung, kidney, liver, decompressive-drainage of hollow viscera- spaces, gastrointestinal (biliary),genitourinary, thoracic, peritoneal lavage, cardiac catheterization External dressings and partial implants — temporary artificial skin, immersion fluids Aids to diagnosis — catheters, probes Orthopedic fixation devices — general (screws, hip pins, traction), bone plates (long bone, spinal, osteotomy), inter- trochanteric (hip nail, nail-plate combination, threaded or unthreaded wires and pins), intramedullary (rods and pins), staples, sutures and surgical adhesives Nanotechnology is a rapidly evolving field that involves material structures on a size scale typically 100 nm or less. New areas of biomaterials applications may develop using nanoscale materials or devices. For example, drug delivery methods have made use of a microsphere encapsulation technique. Nanotechnology may help in the design of drugs with more precise dosage, oriented to specific targets or with timed interactions. Nanotechnology may also help to reduce the size of diagnostic sensors and probes. Transplantation of organs can restore some functions that cannot be carried out by artifi- cial materials, or that are better done by a natural organ. For example, in the case of kidney Kidney not µ Falin success failure many patients can expect to derive benefit from transplantation because an artificial kidney has many disadvantages, including high cost, immobility =f the device, maintenance of Implants the dialyzer, and illness due to imperfect filtration. The functions of the liver cannot be as- _ sumed by any artificial device or material. Liver transplants have extended the lives of people with liver failure. Organ transplants are widely performed, but their success has been hindered due to social, ethical, and immunological problems. Since artificial materials are limited in the functions they can perform, and transplants are limited by the availability of organs and problems of immune compatibility, there is current interest in the regeneration or regrowth of diseased or damaged tissue. Tissue engineering re- fers to the growth of a new tissue using living cells guided by the structure of a substrate made of synthetic material. This substrate is called a scaffold. The scaffold materials are important since they must be compatible with the cells and guide their growth. Most scaffold materials are biodegradable or resorbable as the cells grow. Most scaffolds are made from natural or synthetic polymers, but for hard tissues such as bone and teeth ceramics such as calcium phos- phate compounds can be utilized. The tissue is grown in vitro and implanted in vivo. There have been some clinical successes in repair of injuries to large areas of skin, or small defects in cartilage. The topic of tissue engineering, an areaofcurrentresearchactiv ity, is discussed in Chapter 16. It is imperative that we should know the fundamentals of materials before we can utilize them properly and efficiently. Meanwhile, we also have to know some fundamental properties dentures . . not clear . always to be a biomaterials * not I sizes fits BIOMATERIALS:A NINTRODUCTION 7 a± : mural head - Figure 1-2. (a) Biomechanical analysis of femoral neck fracture fixation. Note that if the im- plant is positioned at 130º, rather than 150º, there will be a force component that will generate a bending moment at the nail-plate junction. The 150º implant is harder to insert and therefore not preferred by surgeons. Reprinted with permission from Massie (1964). Copyright © 1964, Charles C. Thomas. (b) Finite-element model (FEM) of spinal disc fusion. Reprinted with per- mission from Goel et al. (1991). Copyright © 1991, American Association of Neurological Surgeons. 8 and functions of tissues and organs. The interactions between tissues and organs with man- made materials have to be more fully elucidated. Fundamentals-based scientific knowledge can be a great help in exploring many avenues of biomaterials research and development. 4 factors that major " " revision surgery - to fancy name go } repair it again d u new one Putin Figure 1-3. A schematic illustration of probability of failure versus implant period for hip joint replacements. Reprinted with permission from Dumbleton (1977). Copyright © 1977, Taylor & Francis. 1.2. PERFORMANCE OF BIOMATERIALS The performance of an implant after insertion can be considered in terms of reliability. For example, there are four major factors contributing to the failure of hip joint replacements. These are fracture, wear, infection, and loosening of implants, as shown in Figure 1-3. If the probability of failure of a given system is assumed to be f, then the reliability, r, can be ex- pressed as ) 1 - 1 r f ▯1, ( Total reliability rtcan be expressed in termsof the reli abilities of each contributing factor for failure: ) 2 - 1 trrn 1 2,., ( where r l= 1 – f 1 r2= 1 – f2, and so on. Equation (1-2) implies that even though an implant has a perfect reliability of one (i.e., r = 1), if an infection occurs every time it is implanted then the total reliability of the operation is zero. Actually, the reliability of joint replacement procedures hasgreatly improved since they were first introduced. The study of the relationships between the structure and physical properties of biological materials is as important as that of biomaterials, but traditionally this subject has not been treated fully in biologically oriented disciplines. This is due to the fact that in these disciplines BIOMATERIALS :AN INTRODUCTION 9 workers are concerned with the biochemical aspects of function rather than the physical prop- erties of “materials.” In many cases one can study biological materials while ignoring the fact that they contain and are made from living cells. For example, in teeth the function is largely mechanical, so that one can focus on the mechanical properties of the natural materials. In other cases the functionality of thetissuesororgansisso dynamic that it is meaningless to replace them with biomaterials, e.g., the spinal cord or brain. 1.3. BRIEF HISTORICAL BACKGROUND Historically speaking, until Dr. J. Lister's aseptic surgical technique was developed in the 1860s, attempts to implant various metal devices such as wires and pins constructed of iron, gold, silver, platinum, etc. were largely unsuccessful due to infection after implantation. The aseptic technique in surgery has greatly reduced the incidence of infection. Many recent devel- opments in implants have centered around repairing long bones and joints. Lane of England designed a fracture plate in the early 1900s using steel, as shown in Figure 1-4a. Sherman of Pittsburgh modified the Lane plate to reduce the stress concentration by eliminating sharp cor- ners (Figure 1-4b). He used vanadium alloy steel for its toughness and ductility. Subsequently, ® Stellite (Co–Cr-basedalloy)wasfoundtobethemostinertmaterialforimplantationby Zierold in 1924. Soon 18-8 (18 w/o Cr, 8 w/o Ni) and 18-8sMo (2–4 w/o Mo) stainless steels were introduced for their corrosion resistance, with 18-8sMo beingespecially resistant to cor- rosion in saline solution. Later, another alloy (19 w/o Cr, 9 w/o Ni) named Vitallium® was introduced into medical practice. A noble metal, tantalum, was introduced in 1939, but its poor mechanical properties and difficulties in processing it from the ore made it unpopular in ortho- pedics, yet it found wide use in neurological and plastic surgery. During the post-Lister period, the various designs and materials could not be related specifically to the success or failure of an implant, and it became customary to remove any metal implant as soon as possible after its initial function was served. Hospital would have to stock on all sizes , for peoplerw.nt Figure 1-4. Early design of bone fracture plate: (a) Lane, (b) Sherman. 10 CH .1:NTRODUCTION Figure 1-5. The Judet prosthesis for hip surface arthroplasty. Reprinted with permission from Williams and Roaf (1973). Copyright © 1973, W.B. Saunders. Fracture repair of the femoral neck was not initiated until 1926, when Hey-Groves used carpenter's screws. Later, Smith-Petersen (1931) designed the first nail with protruding fins to prevent rotation of the femoral head. He used stainless steel but soon changed to Vitallium . Thornton (1937) attached a metal plate to the distal end of the Smith-Petersen nail and secured it with screws for better support. Smith-Petersen later (1939) used an artificial cup over the femoral head in order to create new surfaces to substitute for the diseased joints. He used glass, Pyrex , Bakelite , and Vitallium . The latter was found more biologically compatible, and 30–40% of patients gained usable joints. Similar mold arthroplastic surgeries were performed successfully by the Judet brothers of France, who used the first biomechanical designed pros- thesis made of an acrylic (methylmethacrylate) polymer (Figure 1-5). The same type of acrylic polymer was also used for corneal replacement in the 1940s and 1950s due to its excellent properties of transparency and biocompatibility. Due to the difficulty of surgical techniques and to material problems, cardiovascular im- plants were not attempted until the 1950s. Blood vesselimplantswattempted with rigid tubes made of polyethylene, acrylic polymer, gold, silver, and aluminum, but these soon filled with clot. The major advancement in vascular implants was made by Voorhees, Jaretzta, and Blackmore (1952), when they used a cloth prosthesis made of Vinyon N copolymer (polyvi- nyl chloride and polyacrylonitrile) and later experimented with nylon, Orlon , Dacron , Tef- ® ® lon , and Ivalon . Through the pores of the various cloths a pseudo- or neointima was formed by tissue ingrowth. This new lining was more compatible with blood than asolidsynthetic surface, and it prevented further blood coagulation. Heart valve implantation was made possi- ble only after the development of open-heart surgery in the mid-1950s. Starr and Edwards (1960) made the first commercially available heart valve, consisting of a silicone rubber ball poppet in a metal strut (Figure 1-6). Concomitantly, artificial heart and heart assist devices have been developed. Table 1-5 gives a brief summary ofhistoricalopments relating to implants. 1 B IOMATERIALS :A N INTRODUCTION 1 ← heart valve need to consider - the blood Flow - size height / Figure 1-6. An early model of the Starr-Edwards heart valve made of a silicone rubber ball and metal cage. Reprinted with permission from the Edwards Laboratories. Table 1-5. Notable Developments Relating to Implants Year Investigator Development Late 18th–19th Various metal devices to fix fractures; wires century and pins from Fe, Au, Ag, and Pt 1860–1870 J. Lister Aseptic surgical techniques 1886 H. Hansmann Ni-plated steel fracture plate 1893–1912 W.A. Lane Steel screws and plates for fracture fixation 1909 A. Lambotte Brass, Al, Ag, and Cu plate 1912 Sherman Vanadium steel plate, first alloy developed exclusively for medical use 1924 A.A. Zierold Stellite (CoCrMo alloy), a better material than Cu, Zn, steels, Mg, Fe, Ag, Au, and Al alloy 1926 M.Z. Lange 18-8sMo (2–4% Mo) stainless steel for greater corrosion resistance than 18-8 stainless steel 1926 E.W. Hey-Groves Used carpenter's screw for femoral neck fracture 1931 M.N. Smith-Petersen Designed first femoral neck fracture fixation nail made originally from stainless steel, ® later changed to Vitallium 1936 C.S. Venable, W.G. Stuck Vitallium; 19 w/o Cr-9 w/o Ni stainless steel 1938 P. Wiles First total hip replacement 1946 J. and R. Judet First biomechanically designed hip prosthesis; first plastics used in joint replacement 1940s M.J. Dorzee, A. Franceschetti Acrylics for corneal replacement 1947 J. Cotton Ti and its alloys 1952 A.B, Voorhees, A. Jaretzta, First blood vessel replacement made of cloth A.H. Blackmore 1958 S. Furman, G. Robinson First successful direct stimulation of heart 1958 J. Charnley First use of acrylic bone cement in total hip replacements 1960 A. Starr, M.L. Edwards Heart valve 1970s W.J. Kolff Experimental total heart replacement 1990s Refined implants allowing bony ingrowth 1990s Controversy over silicone mammary implants 2000s Tissue engineering 2000s Nanoscale materials Modified with permission from Williams and Roaf (1973). Copyright © 1973, W.B. Saunders. 12 PROBLEMS 1-1. a. Determine the probability of failure of a hip joint arthroplasty after 15 and 30 years, assuming the following (t is in years). e h t s i r o t c a f h c i hW . b most important for the longevity of the arthroplasty? –t n o i t c e f n I fi= 0.05e gninesooL flo 0.01e +0.15t erut carF f = 0.01e +0.01t fr +0.1t raeW fw= 0.01e ror re l ac igruS fsu 0.001 ni aP f = 0.005 pn 1-2. Plot the individual failure versus time on a graph similar to that in Figure 1-1. Use any graphics software rather than spreadsheet software to achieve a high-quality graph. Also, plot the total success (t versus time on the same graph. 1-3. How would the failure modes shown in Figure 1-1 differ if an obsolete material such as vanadium steel were used to make the hip joint implant (femoral stem)? 1-4. Discuss the feasibility and implications of replacing an entire arm. 1-5. Discuss the ethical problems associated with using fetal brain tissue for transplanta- tion purposes to treat Parkinson's disease; or fetal bone marrow to treat leukemia. 1-6. Discuss the advantages and disadvantages of kidney transplantation as compared to the use of a dialysis machine. 1-7. Discuss the pros and cons of medical device litigation such as that associated with silicone breast implants in the United States. Be brief. SYMBOLS/DEFINITIONS Latin Letters f: Probability of failure r:Reliabilityorprobabilityofsuccess Terms Biomaterial: A synthetic material used to replace part of a living system or to function in in- timate contact with living tissue. Also read the various definitions given by other authors in the text. Biomechanics: The study of the mechanical laws relating to the movement or structure of liv- ing organisms. Biological material: A material produced by a living organism. Biocompatibility: Acceptance of an artificial implant by the surrounding tissues and by the body as a whole. The biomaterial must not be degraded by the body environment, and its presence must not harm tissues, organs, or systems. If the biomaterial is designed to be degraded, then the products of degradation should not harm the tissues and organs. CDRH (Center for Devices and Radiological Health): Branch of the FDA that administers medical devices-related regulations. 3 B IOMATERIALS :A N NTRODUCTION 1 Cytotoxicity: Toxic to living cells. ETO (ethylene oxide gas, (CH ) O2 2A flammable toxic gas used as a sterilization agent. FDA (Food and Drug Administration): Government agency regulating testing, production, and marketing of food and drugs including medical devices within the United States. FEM or FEA (finite-element modeling/analysis): Stress and strain analysis of a structural body using computer software. The object is divided into small elements that are amena- ble to analysis. Boundary conditions are applied and the distribution of stresses and strains calculated. Gamma (J▯-radiation: The emission of energy as short electromagnetic waves that cause 60 ionization. The radioactive is6tope Co is an effective source of the radiation. To be effec- tive for sterilization, about 10y (J/kg) is needed. GMP (Good Manufacturing Practices): Medical devices are made in a clean room condition to prevent any contamination. Such practices are required by the FDA for manufacture of implants. Hemolysis: Lysis (dissolution) of erythrocytes in blood with the release of hemoglobin. ISO (International Standard Organization): ISO9000 is a set of standards related to medical devices necessary to maintain an efficient and quality system. A standard focuses on con- trolling organizations rather than specific requirements for final products. ASTM 13.01 focuses on specific products in the United States. Microsphere:Amicroscopichollowsphere,especially of a protein or synthetic polymer. Mutagenicity: The capacity of a chemical or physical agent to cause permanent genetic altera- tions. Nanotechnology:Thebranchof technology that deals with dimensions and tolerances of less than 100 nanometers — for example, manipulation of individual atoms and molecules. PMA (Premarket Approval): Some medical devices can be approved by the FDA without ex- tensive tests required by FDA through MDE (medical device exemptions) 510K ( Pyrogenic: Caused or produced by combustion or the application of heat-inducing fever. Sensitization: Making (an organism) abnormally sensitive to a foreign substance, such as a metal. Systemic: Denoting the part of the circulatory system concerned with transportation of oxygen to and carbon dioxide from the body in general. Tissue engineering: Generation of new tissue using living cells, optimally the patient’s own cells, as building blocks, coupled with biodegradable materials as a scaffold. BIBLIOGRAPHY Encyclopedias and Handbooks 1. Biomedical engineering handbook. Boca Raton, FL: CRC Press 2. Encyclopedia of medical engineering. New York: J. Wiley 3. Handbook of bioactive ceramics, Vols. I and II. Boca Raton, FL: CRC Press 4. Handbook of biomaterials evaluation. New York: McMillan 5. Handbook of materials for medical devices. Materials Park, OH: ASM International 14 CH .1:INTRODUCTION Journals on Biomaterials 1. Biomaterials 2. Bio-Medical Materials and Engineering 3. Journal of Biomedical Materials Research, Part A, and Part B: Applied Biomaterials Meetings on Biomaterials 1. Society for Biomaterials, Annual 2. Orthopedic Research Society, part of American Association of Orthopedic Surgeons, Annual 3. American Society for Artificial Internal Organs, Annual Standards 1. American Society for Testing and Materials, Annual Book of ASTM, Vol 13.01 2. International Standard Organization, ISO Journals and Books Bechtol CO, Ferguson AB, Liang PG. 1959. Metals and engineering in bone and joint surgery. London: Balliere, Tindall, & Cox. Black J. 1981. Biological performance of materials. New York: Dekker. Black J. 1992. Biological performance of materials: fundamentals of biocompatibility. New York: Dek- ker. Bloch B, Hastings GW. 1972. Plastics materials in surgery. Springfield, IL: Thomas. Block MS, Kent JN, Guerra LR, eds. 1997. Implants in dentistry. Philadelphia: W.B. Saunders. Bokros JC, Atkins RJ, Shim HS, Atkins RJ, Haubold AD, Agarwal MK. 1976. Carbon in prosthetic de- vices. In Petroleum derived carbons, pp. 237–265. Ed ML Deviney, TM O'Grady. Washington, DC: American Chemical Society. Boretos JW 1973. Concise guide to biomedical polymers. Springfield, IL: Thomas. Boretos JW, Eden M, eds. 1984. Contemporary biomaterials. Park Ridge, NJ: Noyes. Brånemark P-I, Hansson BO, Adell R, Breine U, Lidstrom J, Hallen O, Ohman A. 1977. Osseous inte- grated implants in the treatment of the edentulous jaw, experience from a 10-year period. Stock- holm: Almqvist & Wiksell International. Brown JHU, Jacobs JE, Stark L. 1971. Biomedical engineering. Philadelphia: Davis. Brown PW, Constantz B, eds. 1994. Hydroxyapatite and related materials. Boca Raton, FL: CRC Press. Bruck SD. 1974. Blood compatible synthetic polymers: an introduction. Springfield, IL: Thomas. Bruck SD. 1980. Properties of biomaterials in the physiological environment. Boca Raton, FL; CRC Press. Chandran KB. 1992. Cardiovascular biomechanics. New York: New York UP. Charnley J. 1970. Acrylic cement in orthopaedic surgery. Edinburgh and London: Churchill/Livingstone. Dardik H, ed. 1978. Graft materials in vascular surgery. Chicago: Year Book Medical Publishers. de Groot K, ed. 1983. Bioceramics of calcium phosphate. Boca Raton, FL: CRC Press. Ducheyne P, Van der Perre G, Aubert AE, eds. 1984. Biomaterials and biomechanics. Amsterdam: El- sevier Science. Dumbleton JH. 1977. Elements of hip joint prosthesis reliability. J Med Eng Technol 1:341–346. Dumbleton JH, Black J. 1975. An introduction to orthopedic materials. Springfield, IL: Thomas. Edwards WS. 1965. Plastic arterial grafts. Springfield, IL: Thomas. Gebelein CG, Koblitz FF, eds. 1980. Biomedical and dental applications of polymers: polymer science and technology. New York: Plenum. Geesink RGT. 1993. Hydroxyapatite-coated hip implants: experimental studies. In Hydroxyapatite- coatings in orthopedic surgery, pp. 151–170. Ed RGT Geesink, MT Manley. New York: Raven Press. 5 B IOMATERIALS :A N NTRODUCTION 1 Goel VK, Lim T-H, Gwon JK, Chen J-Y, Winterbottom JM, Park JB, Weinstein JN, Ahn J-Y. 1991. Effects of an internal fixation device: a comprehensive biomechanical investigation. Spine 16:s155– s161. Greco RS. 1994. Implantation biology: the host response and biomedical devices. Boca Raton, FL: CRC Press. Guelcher SA, JO Hollinger. 2006. An introduction to biomaterials. Boca Raton, FL: CRC, Taylor & Francis Hastings GW, Williams DF, eds. 1980. Mechanical properties of biomaterials, Part 3. New York: Wiley. Helmus MN, ed. 2003. Biomaterials in the design and reliability of medical devices. New York: Springer. Helsen JA, Breme HJ. 1998. Metals as biomaterials. Wiley Series in Biomaterials Science and Engineer- ing. New York: Wiley. Hench LL, ed. 1994. Bioactive ceramics: theory and clinical applications. Bioceramics, Vol. 7. Oxford: Pergamon/Elsevier Science. Hench LL, Ethridge EC. 1982. Biomaterials: an interfacial approach. New York: Academic Press. Hench LL, Jones JR, eds. 2005. Biomaterials, artificial organs and tissue engineering. Cambridge: Woodhead. Hench LL, Wilson J, eds. 1993. An introduction to bioceramics. London: World Scientific. Hill D. 1998. Design engineering of biomaterials for medical devices. New York: Wiley. Homsy CA, Armeniades CD. 1972. Biomaterials for skeletal and cardiovascular applications. New York: Wiley Interscience. Kawahara H, ed. 1989. Oral implantology and biomaterials. Amsterdam: Elsevier Science. King PH, Fries RC. 2003. Design of biomedical devices and systems. New York: Dekker. Kronenthal RL, Oser Z, eds. 1975. Polymers in medicine and surgery. New York, Plenum. Kühn K-D. 2000. Bone cements: up-to-date comparison of physical and chemical properties of commer- cial materials. Berlin: Springer.


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